Delivery system for a medicament and method for the assembly thereof

ABSTRACT

An indicating device for use with a dispensing device that dispenses metered dosages of a medicament from a container having a valve moveable between an open and closed position. In a preferred embodiment, the container is reciprocally moveable within the housing along a longitudinal axis. The housing preferably has a well adapted to receive a valve stem and an exhaust port. The well communicates with the port such that the metered dosage of medicament is dispensed through the port when the valve is moved to the open position. An indicator assembly comprises an indicator member that includes dosage indicia visible to a user. In a preferred embodiment, the indicator assembly is provided in an indicator module. A method for dispensing measured dosages is also provided, along with a kit capable of being assembled as an inhalation device. A delivery system having a key member and a key entry passageway is also provided.

[0001] This application is a continuation-in-part of application Ser.No. 09/008,184, filed Jan. 16, 1998, and entitled Aerosol DispensingDevice, the disclosure of which is hereby incorporated herein byreference. No license, expressed or implied, is intended to be grantedto application Ser. No. 09/008,184, or any patents issuing therefrom, byreason of the incorporation by reference herein.

BACKGROUND

[0002] The present invention relates generally to an indicating device,and in particular, to an indicating device for indicating the number ofmetered dosages of a substance, and in particular a medicament, thathave been dispensed by, or remain in, a dispensing device.

[0003] Delivery systems, and in particular, dispensing devices, havebeen developed that include a counting or dose indicating device toindicate the number of metered doses of substance that have beendispensed from the delivery system, or to indicate the number of dosesremaining therein. For example, patients have certain conditions thatcan be treated with medicaments dispersed in an aerosol and administeredto the patient by inhalation. In one format, the aerosol and medicamentsare contained in a container, and dispensed in metered, or measured,dosages with the dispensing device, which can include an actuator boot.In such an arrangement, it can be important for the patient to be ableto ascertain the number of metered doses remaining in the container,either by an indication of the number remaining therein or by knowledgeof the number already dispensed therefrom, such that the patient is notcaught unaware with an empty container when in need of the medicament.Thus, it may be important for the dispensing device to provide anaccurate indication of either the number of doses remaining in thecontainer, or the number of doses already dispensed therefrom.

[0004] Typically, a conventional aerosol container includes a body and avalve stem which can be depressed relative to the body so as to emit themetered dose of aerosol and medicament. The container is usuallysupplied with a predetermined number of metered doses, e.g., on theorder of about 200, such that the counting of the number of valve stemdepressions, and corresponding number of dispensed metered doses, can bedirectly correlated with the number of doses remaining in the container.

[0005] In operation, the container is typically received within ahousing of the dispensing device, wherein the valve is brought intoengagement with a support block in the housing. The user administers themedicament by moving the container relative to the housing so as todepress the valve stem and internal valve and thereby release a metereddose, which is typically administered to the user through a port ormouthpiece extending from the housing. In an alternative deliverysystem, the metered dose can be first discharged into a chamber, andthereafter administered to the patient. After the metered dose isdischarged from the container, the valve stem, which is typically springloaded, biases the container away from the support block so as to againmove the container relative to the housing. In this way, a metered doseof medicament is discharged by each cycle of linear reciprocal movementof the container relative to the housing.

[0006] Some dispensing devices have indicating devices that convert thelinear reciprocal movement of the container relative to the housing intoa one-way, or single-cycle, movement of an indicator, wherein theindicator identifies the relative fullness of the container, the numberof metered doses remaining therein or the number of doses alreadyadministered. Although these dispensing devices with indicators haveprovided the advantage of generally being able to keep track of thenumber of dosages, there remains room for improvement. For example,indicating devices of this nature may include complex moving parts whichcan be difficult to assemble and expensive to manufacture. Such devicesmay also be susceptible to counting inaccuracies due to theconfiguration of the indexing or mating parts, or require excessiveamounts of space within the housing to accommodate the relatively largeor numerous moving parts. Others still may impede or interfere with theairflow and medicament being dispensed from the inhalation device.Alternatively, some devices use electrical circuitry to count or recordthe dispersements. Such devices can be relatively expensive tomanufacture, however, and typically require a power source which may besusceptible to damage in various environments, such as moist conditions.

SUMMARY

[0007] Briefly stated, in one aspect the invention is directed to adispensing device having an indicating device. The dispensing devicedispenses metered dosages of a substance from a container having a valvemoveable between a closed position and an open position. The containerdispenses a metered dosage when the valve, actuated by a valve stem, ismoved to the open position. In an exemplary embodiment, the dispensingdevice includes a housing adapted to support the container reciprocallymoveable within the housing along a longitudinal axis. The housing has awell adapted to receive the valve stem and an exhaust port. The wellcommunicates with the port such that the metered dosage of substance isdispensed through the port when the valve stem is moved to the openposition.

[0008] In one embodiment of the indicating device, an indicator assemblyincludes a worm rotatably mounted in the housing about an axistransverse to the longitudinal axis and responsive to the movement ofthe reciprocal movement of the container within the housing such thatthe longitudinal movement of the container relative to the housingcauses the worm to rotate about its axis. An indicator member includesdosage indicia visible to a user and a circular gear mounted in thehousing about an axis transverse to the axis of the worm andnon-parallel to the longitudinal axis. The circular gear engages theworm.

[0009] In a preferred embodiment, the indicator assembly furtherincludes a ratchet wheel rotatably mounted in the housing and adapted tobe responsive to the reciprocal movement of the container relative tothe housing along the longitudinal axis. The ratchet wheel is connectedto the worm such that rotation of the ratchet causes the worm gear torotate about its axis. In addition, an actuator member including an armis preferably mounted within the housing and is adapted to move inresponse to the movement of the container and operably engage theratchet wheel so as to rotate the wheel in response to the longitudinalmovement of the container relative to the housing. Also in the preferredfirst embodiment, the indicator member includes an indicator wheelcoaxially mounted with the circular gear on an axle defining the axis ofrotation of the indicator member. The dosage indicia are applied to asurface of the indicator wheel.

[0010] In another embodiment of the indicating device, the housingcomprises at least one engagement member and the indicator assemblyincludes a plurality of indicator members, including at least a firstand second indicator member. The plurality of indicator members arecoaxially mounted in the housing. At least one of the first and secondindicator members includes an advancement member, while at least theother of the first and second indicator members includes a plurality ofteeth. In operation, the first indicator member is rotated relative tothe second indicator member such that the engagement member selectivelyengages and biases the advancement member into operable engagement withat least one of the plurality of teeth so as to rotate the secondindicator member an incremental amount.

[0011] In a preferred embodiment, an actuator member is mounted in thehousing and is responsive to the movement of the container. The actuatormember selectively engages at least one of the plurality of teeth on thefirst indicator member so as to advance the first indicator member anincremental amount in response to the movement of the container relativeto said housing. A spring is preferably disposed in the housing to biasthe actuator member into engagement with the container.

[0012] In another aspect of the invention, the indicator assembly,including the ratchet wheel, worm, actuator member and indicator memberof the first embodiment, are mounted within an indicator module which isadapted to be mounted within the dispenser housing. Similarly, withrespect to the second embodiment, the indicator assembly, including theplurality of indicator members, advancement member, spring and ratchetmember, are supported in the indicator module. The module preferablyincludes a first and second member which are joined to form an enclosureor housing, and which support any one or more of the ratchet wheel,worm, actuator member and indicator member of the first embodimenttherein, or the plurality of indicator members, advancement member,spring and actuator member of the second embodiment. In the secondembodiment, the engagement members are also preferably disposed in themodule housing.

[0013] In another aspect of the invention, a key member is mounted toone of the container and the housing and is shaped to be received in apassageway formed in the other of the housing and container.

[0014] In yet another aspect of the invention, a method is provided fordispensing measured dosages from the container. In one embodiment, themethod includes the steps of moving the container along the longitudinalaxis so as to move the valve stem, and valve, to the open positionwherein a metered dosage is discharged. The longitudinal movement of thecontainer within the housing causes the ratchet gear to rotate apredetermined angular amount, which, in turn, causes the worm to rotateabout its axis. The worm then engages the circular worm gear of theindicator member so as to rotate the worm gear about its axis.

[0015] Alternatively, in a second embodiment, the first indicator memberis rotated a predetermined amount in response to the movement of thevalve between a closed and open position, or vice versa. Upon apredetermined number of movements of the valve, the first indicatormember causes the second indicator member to rotate a predeterminedamount.

[0016] In another aspect of the invention, a method is provided forassembling a dispenser comprising a housing, a container and anindicator module.

[0017] In yet another aspect of the invention, a kit includes componentscapable of being assembled as a dispensing device for dispensing metereddosages of a substance from a container. The kit includes a housing, acontainer having a plurality of metered dosages of the substance and anindicator module having an indicator member.

[0018] The present invention provides significant advantages over otherindicating devices. In particular, with respect to the first embodimentof the indicating device, the worm provides for a compact drivecomponent that does not occupy excess space within the housing.Moreover, the worm provides for high gear reduction ratios whilemaintaining a continuous engagement with the circular worm gear. Thecontinuous engagement of the worm and circular gear ensures that theaccuracy of the counting device is maintained, while simultaneouslysimplifying the manufacturing and assembly process.

[0019] The use of a circular gear having an axis non-parallel, andpreferably transverse or perpendicular to the longitudinal movement ofthe container within the housing, also provides several advantages.Importantly, the gear can be easily mounted to the housing with aninexpensive and easy-to-install axle. Thus, the circular gear providesfor a compact single-cycle device that fits easily into the housing, andwhich maintains continuous engagement with the worm gear for improvedand accurate indexing of the indicator member. Moreover, the componentsare arranged so as to not interfere with or otherwise impede the airflow from the valve stem to the exhaust port of the housing. Inaddition, the indicator wheel, which is preferably coaxially mountedwith the worm gear, provides an ideal planar surface for displaying thedosage indicia. The indicia can be easily viewed by the user through theviewing window.

[0020] The second embodiment of the indicating device provides similaradvantages. In particular, the plurality of indicator members can bemounted in a compact arrangement to provide accuracy and reliabilityunder various operating conditions but which does not impede or obstructthe airflow to the user. Moreover, the various parts are relativelyinexpensive to manufacture and assemble. The indicia, which are visibleto the user through the viewing window, are easy to read and readilyaccessible to the user.

[0021] The indicator module, with any of the various embodiments ofindicating assemblies disposed therein, also presents severaladvantages. In particular, the self-contained unit can be separatelymanufactured and installed as needed in any number of conventional typesof dispensing devices with minimal modification thereof. Moreover, themodule can be easily installed without interfering with or otherwiseimpeding the air flow from the valve stem to the exhaust port andultimately to the user.

[0022] The key member also presents several advantages. In particular,differently configured key members and passageways can be installedbetween containers holding different substances such as medicaments andcorresponding delivery system housings so as to prevent the user frominterchanging various containers and housings so as to thereby alter thenumber of doses being counted. The key member and passageway can alsoprevent a user from using the wrong delivery system for a particularcontainer having a particular substance, such as a medicament.

[0023] The present invention, together with further objects andadvantages, will be best understood by reference to the followingdetailed description taken in conjunction with the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0024]FIG. 1 is a perspective view of a dispensing device with a viewingwindow revealing dosage indicia.

[0025]FIG. 2 is a perspective view of one embodiment of the dispensingdevice with a portion of the housing cut away.

[0026]FIG. 3 is a perspective view of one embodiment of the indicatorassembly.

[0027]FIG. 4 is a perspective view of an alternative embodiment of thedispensing device.

[0028]FIG. 5 is a perspective view of the dispensing device shown inFIG. 4 with a portion of the housing cut away.

[0029]FIG. 6 is a perspective view of a container, a dispenser housingand one embodiment of an indicator module with a portion of the housingcut away.

[0030]FIG. 7 is an exploded perspective view of a container, a dispenserhousing and one embodiment of the indicator module with a portion of thehousing cut away.

[0031]FIG. 8 is an exploded perspective view of one embodiment of theindicator module.

[0032]FIG. 9 is an exploded perspective view of the indicator modulefrom the opposite side as shown in FIG. 8.

[0033]FIG. 10 is an exploded perspective view of a container, and analternative embodiment of the dispenser housing and the indicatormodule.

[0034]FIG. 11 is a perspective view of the alternative embodiment of theindicator module shown in FIG. 10.

[0035]FIG. 12 is a section cut of a housing and an indicator modulemounted therein.

[0036]FIG. 13 is a top view of one embodiment of the indicator module.

[0037]FIG. 14 is a rear view of the indicator module shown in FIG. 13.

[0038]FIG. 15 is a cross-sectional view of the indicator module takenalong line 15-15 of FIG. 13.

[0039]FIG. 16 is a cross-sectional view of the indicator module takenalong line 16-16 of FIG. 13.

[0040]FIG. 17 is a cross-sectional view of the indicator module takenalong line 17-17 of FIG. 13.

[0041]FIG. 18 is a cross-sectional view of the indicator module takenalong line 18-18 of FIG. 13.

[0042]FIG. 19 is a perspective view of an alternative embodiment of themodule.

[0043]FIG. 20 is a cross-sectional view of the indicator module takenalong line 20-20 of FIG. 14.

[0044]FIG. 21 is an exploded view of a container, a key member and anindicator module.

[0045]FIG. 22 is a top view of the key member.

[0046]FIG. 23 is a cross-sectional view of the key member taken alongline 23-23 of FIG. 22.

[0047]FIG. 24 is a perspective view of a container and an alternativeembodiment of the indicator module mounted in a dispenser housing with aportion of the housing cut away.

[0048]FIG. 25 is an exploded perspective view of an alternativeembodiment of an indicator module, key member and indicator assembly.

[0049]FIG. 26 is a top perspective view of a first member of oneembodiment of the indicator module housing.

[0050]FIG. 27 is a bottom perspective view of the member shown in FIG.26.

[0051]FIG. 28 is a perspective view of one embodiment of an indicatormember.

[0052]FIG. 29 is an opposite perspective view of the indicator membershown in FIG. 28.

[0053]FIG. 30 is a top perspective view of a second member of oneembodiment of the indicator module with an axle installed therein.

[0054]FIG. 31 is a perspective view of an actuator member.

[0055]FIG. 32 is a perspective view of a container with an alternativeembodiment of a key member installed thereon positioned above oneembodiment of an indicator module.

[0056]FIG. 33 is a perspective view of an alternative embodiment of thekey member.

[0057]FIG. 34 is an exploded perspective view of an alternativeembodiment of a key member being applied to a container.

[0058]FIG. 35 is a cross-sectional view of an indicator module showingan advancement member of a first indicator member, an engagement memberand a second indicator member.

[0059]FIG. 36 is a cross-sectional view of the advancement member of thefirst indicator member as it is first engaged by the engagement memberin the indicator module housing.

[0060]FIG. 37 is a cross-sectional view of the advancement member as itis biased by the engagement member into engagement with the secondindicator member so as to rotate the second indicator member.

[0061]FIG. 38 is a cross-sectional view of the advancement member as itis released by the engagement member and disengages from the secondindicator member.

[0062]FIG. 39 is an exploded perspective view of an alternativeembodiment of an indicator module and indicator assembly.

[0063]FIG. 40 is an enlarged side view of an actuator member in adisengaged position adjacent a first indicator member.

[0064]FIG. 41 is a side view of the actuator member engaging the firstindicator member with the non-return being biased outwardly.

[0065]FIG. 42 is a perspective side view of an alternative embodiment ofan indicator member.

[0066]FIG. 43 is an opposite perspective side view of the indicatormember of FIG. 42.

[0067]FIG. 44 is a cross-sectional view of an advancement member on afirst indicator member, a second indicator member and an engagementmember.

[0068]FIG. 45 is a cross-sectional view of the advancement member as itis first engaged by the engagement member.

[0069]FIG. 46 is a cross-sectional view of the advancement member as itis biased by the engagement member into engagement with the indicatormember.

[0070]FIG. 47 is a cross-sectional view of the advancement member as itis further biased by the engagement member into engagement with thesecond indicator member.

[0071]FIG. 48 is a perspective view of an alternative embodiment of anindicator assembly disposed on a lower member of the module housing.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

[0072] Referring to the drawings, and in particular FIGS. 1, 4, 6, 7 and24, a delivery system, configured as a dispensing device, or dispenser,is shown as including a housing 10, or actuator boot, and a container100 disposed therein. The housing 10 has a longitudinally extendingcavity 12 shaped to receive the container. A top portion of the housingis generally open such that the container can be inserted in the housingthrough opening 14 and be installed therein with a bottom end 102 of thecontainer protruding from the housing and exposed to the user foractuation.

[0073] It should be understood that the term “delivery system,” as usedherein, is meant to include a system or apparatus for delivering asubstance from a container, reservoir, or similar repository, to a user,and includes but is not limited to the disclosed dispensing device,which delivers the substance to the user in the form of an aerosol thatis inhaled by the user. The term “dispensing device,” as used herein, ismeant to include devices that extrude, spray or otherwise feed out ordeliver a substance in convenient units, and includes, but is notlimited to, the disclosed inhalation device which delivers metereddosages of a substance in aerosol form for inhalation by the user.

[0074] The term “longitudinal” as used herein is intended to indicatethe direction of the reciprocal movement of the container relative tothe housing. The terms “top,” “bottom,” “upwardly” and “downwardly” areintended to indicate directions when viewing the inhalation devices asshown in the Figures, but with the understanding that the container isinverted such that the top surface thereof is located adjacent thebottom of the housing and vice versa.

[0075] As shown in FIGS. 5, 6 and 7, a cylindrical support block 16having a well 18 is formed in a bottom portion 22 of the housing. Anorifice 20 penetrates the support block to communicate with a bottomportion of the well. A mouthpiece 24, intended for insertion into themouth of a patient, forms an exhaust port 26 that communicates with theorifice and well. The mouthpiece 24 extends laterally from the housingso as to facilitate insertion of the mouthpiece into the mouth of thepatient.

[0076] The container 100 is formed as a cylindrical canister 104 havinga 106 hub disposed on a top surface 108 thereof. A valve stem 110extends longitudinally from the hub. The valve stem extends coaxiallyfrom the canister and is biased outwardly therefrom by a spring (notshown) mounted within the canister. The container 100 is mounted in thehousing by press fitting the valve stem 110 in the well 18 of thesupport block. It should be understood that the container can beconfigured in a variety of shapes and sizes, and that the substancecontained therein can be released by any number of valve systems thatare well known in the art. It should also be understood that the valvesystem can be actuated by a variety of actuators, including, but notlimited to, various pumps, levers, actuator boots, buttons and the like.In such embodiments, the valve system can be actuated by an actuatormoveable relative to the container and housing such that the containerremains stationary relative to the housing.

[0077] In a preferred embodiment, the container 100 is filled with asubstance which is dispensed therefrom in specific metered doses bydepressing or moving the valve stem 110 from an extended closed positionto a depressed open position, which in turn opens the valve or valvesystem. Preferably the substance is a medicament, although it should beunderstood that the container could be used to hold a variety ofnon-medicinal substances, including, but not limited to, variousliquids, foams or aerosols that can be delivered by various deliverysystems, and/or dispensing devices. A medicament is defined as asubstance that can be used in therapy, such as for various therapeutictreatments, including the treatment of diseases (e.g., respiratoryailments) and for the relief of pain, and should be understood toinclude medicines and medicinal substances in general. A single metereddose is dispensed from the container by each reciprocal, longitudinalmovement of the valve stem and attendant opening and closing of thevalve. The medicament is typically delivered to the user, or patient,through their mouth and/or nose in the form of an aerosol, spray orliquid.

[0078] In operation, the opening of the valve stem and valve is effectedby moving the container 100 reciprocally within the housing 10 along alongitudinal axis, defined by the valve stem and the reciprocal movementof the container, by depressing the exposed bottom end 102 of thecanister relative to the housing 10 so as to move the valve stem 110 tothe open position as it is supported within the well by the supportblock. Alternatively, an actuator can be moved to open the valve systemof the container, which can remain stationary with respect to asupporting housing, a cap and/or an indicating device mounted thereto.For example, the actuator can be attached to the end of the container inthe form of a pump device or the like.

[0079] Referring to FIGS. 5-7, as the valve stem is moved to the openposition, the container dispenses a metered dose of the substance inaerosol form through the well 18 and orifice 20 and into the exhaustport. The substance in aerosol form is then transmitted to the userthrough the exhaust port of the mouthpiece by way of either aself-generated or assisted airflow. Alternatively, metered doses ofliquids and the like can be dispensed from the container.

[0080] In other delivery systems, which may also include a dispensingdevice, the housing and holder for the container are attached to acomponent having a chamber with an output end. Examples of these kindsof delivery systems and dispensing devices are shown for example in U.S.Pat. No. 5,012,803, issued May 7, 1991, and U.S. Pat. No. 4,460,412,issued Sep.11, 1984, the entire disclosures of which are herebyincorporated herein by reference. (No license, expressed or implied, isintended to be granted to either of these patents by reason of theincorporation by reference herein.) In these kinds of delivery systems,the component having the chamber can be adapted to receive themouthpiece of the housing, or it can be integrally connected with aholder supporting the container. In either embodiment, the metered doseof substance, preferably a medicament, in aerosol is first dispensedfrom the container into the chamber, and thereafter inhaled by the user.

[0081] In a preferred embodiment, the container 100 is intended todispense a predetermined number of metered doses of substance. Forexample, conventional inhaler containers typically hold on the order of100 to 200 metered doses. In operation, it is important that the user beaware of the number of metered doses remaining in the container suchthat the user is not caught unaware with an empty canister when in needof the substance, such as a medicament.

[0082] Now referring to FIGS. 2 and 3, a dispensing device, configuredas an aerosol dispenser, is shown as including a housing, a containermounted therein as described above and an indicator assembly. Theindicator assembly includes a ratchet gear 32 coaxially mounted with aworm 40 on an axle 42 in a lower portion of the housing. A plurality ofteeth 34 are formed about the periphery of the ratchet gear. The teeth34 are cut or formed with a tapered surface 36 and engagement surface38. In a preferred embodiment, the ratchet and worm are formed out of ahard durable plastic. It should be understood, however, that othermaterials such as metal would also work. The ratchet and worm can bemade as separate parts, or molded as a single integral member.

[0083] In a preferred embodiment, the axle 42 and worm 40 define an axisof rotation transverse, or perpendicular, to the longitudinal axisdefined by the valve stem and reciprocal movement of the containerrelative to the housing. Opposite ends of the axle 42 are rotatablysupported in the housing.

[0084] Also as shown in FIGS. 2 and 3, an indicator member 50 comprisesa circular worm gear 52 and indicator wheel 58 coaxially mounted on anaxle. In a preferred embodiment, the axle 56 defines an axis of rotationtransverse to the axis defined by the worm and also transverse to thelongitudinal axis defined by the reciprocal movement of the containerrelative to the housing. The axle 56 is rotatably supported in thehousing. Teeth 54 are formed around the periphery of the worm gear 52and are shaped to permanently engage the worm 40. As shown in FIG. 2,the indicator wheel 58 has a planar face 60 which is exposed to thepatient through a viewing window 28 formed in the housing.

[0085] The ratchet gear 32, worm 40, worm gear 52 and indicator wheel 58provide an ideal arrangement for indicating the number of dosesremaining in the container, or the number dispensed therefrom. Inparticular, relatively high reduction ratios are made possible throughuse of the ratchet, worm and worm gear without the correspondingrequirement of providing extremely fine teeth on one or more of theratchet gear and worm gear. Moreover, the worm and worm gear interfaceavoids the associated inaccuracies introduced by the mating, andpotential skipping, of conventional spur gears having fine teeth.Furthermore, the installation of the indicator member is effected by theinstallation of a simple axle which can be supported in a plurality ofpositions and angular orientations within the housing. Importantly, thehigh reduction ratio realized with the worm 40 allows for the worm gear52 to have a relatively small diameter, such that it can be easilymounted within small spaces within the housing. Indeed, as shown inFIGS. 6 and 12, the entire indicator assembly can be mounted behind thesupport block 16 and below the upper surface 17 thereof such that theassembly does not interfere with the dispensing of the medicament fromthe orifice or with the airflow generated by the patient inadministering the medicament.

[0086] Referring to FIG. 5, an actuator member 70 is configured as apost member 72 moveably supported in the housing along an axis parallelto the longitudinal axis defined by the reciprocal movement of thecontainer within the housing. In an alternative embodiment shown inFIGS. 7-9, the post member includes an upper portion 74, a middleportion 76 and a lower portion 78. A resilient arm member 80 extendsfrom the middle portion of the post member and terminates in a taperedhook member 82 shaped to selectively engage one of the ratchet wheelteeth. The middle portion 76 is defined by upper and lower stop surface84, 86. A spring 88 is disposed about the lower portion 78 of the postmember and engages the lower stop surface 86 so as to bias the actuatormember upwardly against the top surface 108 of the canister as shown inFIG. 7. Although a compression spring is shown in the Figures, it shouldbe understood that cantilever, torsion, leaf and tension springs, andthe like, would also work to bias the actuator member upwardly intoengagement with the container. The springs can be made of metal orplastic.

[0087] In an alternative embodiment, shown in FIGS. 2 and 3, actuatormember 90 includes locking ring 92 and a resilient arm member 94extending longitudinally downwardly therefrom. A longitudinal slit 96 isformed in the locking ring so as to allow for the locking ring 92 to beexpanded and disposed around the hub 106 (shown in FIG. 5) of thecanister in a snap fit configuration such that the valve stem of thecontainer extends through opening 98 of the locking ring. A distal endof the resilient arm member terminates in a hook member 95 which isshaped to selectively engage the teeth of the ratchet wheel.

[0088] In the operation of the embodiment shown in FIGS. 6-9, 13-18 and20, the container is moved longitudinally within the housing so as todepress the valve stem to the open position so as to open the valve asexplained above. As the container is moved downwardly within thehousing, the actuator member 70 is moved longitudinally downward suchthat the hook member 82 engages the ratchet wheel and rotates it apredetermined angular amount corresponding to the pitch of the teeth.When the container is released by the user, the spring (not shown)within the container biases the container upwardly within the housingalong the longitudinal axis such that the valve stem 110 is moved to theclosed position within the container so as to close the valve. As thecontainer moves upwardly, the resilient arm member 80 is biasedlaterally outward as a tapered end portion of the hook member 82 slidesagainst the tapered surface 36 of one of the ratchet teeth. As thecontainer and resilient arm member reach the top of the stroke, whereinthe valve stem is moved completely to the closed position, the resilientarm member 80 returns to its normal straightened configuration as thehook member 82 slips past the tapered surface of one of the teeth so asto be positioned over the engagement surface 38 of that tooth 34 for thenext cycle.

[0089] Alternatively, the operation of the ratchet wheel can be reversedas shown in FIG. 3. In this embodiment, the resilient arm member 94 isbiased outwardly by the tapered surface of one of the ratchet gear teethon the downstroke. At the bottom of the stroke, the hook member 95 slipsinto an underlying relationship with the engagement surface of thetooth. When the container is released by the user, the spring (notshown) within the canister biases the container upwardly within thehousing along the longitudinal axis such that the valve stem is moved tothe closed position within the container. As the container movesupwardly with respect to the housing, the resilient arm member 94 moveslongitudinally upward such that the hook member 95 engages theengagement surface 38 of one of the teeth and thereby rotates theratchet wheel an incremental amount.

[0090] In the embodiment shown in FIGS. 6-9, 13-18 and 20, it is theforce of the spring 88 that moves the arm member 80 upwardly so as toreturn the actuator member in preparation for another cycle. In thealternative embodiment shown in FIGS. 2 and 3, it is the movement of thecontainer, as it is biased upwardly by the internal spring acting on thevalve stem, that causes the locking ring 92 and arm member 94 to moveupwardly and thereby rotate the ratchet gear.

[0091] Referring to FIGS. 8 and 17, a resilient non-return member 200engages the ratchet gear adjacent the hook member so as to ensure thatthe rotation of the ratchet gear is unidirectional. Alternatively, thenon-return member can be positioned to engage the ratchet gear oppositethe actuator arm member. The non-return member includes an end portionadapted to engage the engagement surface of the ratchet gear teeth. Asthe ratchet gear is rotated by the actuator, the non-return memberslides along the tapered surface of one of the teeth of the ratchetwheel and does not interfere with the rotation thereof.

[0092] The rotation of the ratchet gear causes the worm 40 to rotate adesired predetermined amount. It should be understood that the desiredamount of rotation is dependent upon the diameter of the ratchet wheeland the number of teeth positioned thereabout. Rotation of the worm,which permanently engages the teeth of the worm gear, causes the wormgear and indicator wheel to rotate a predetermined incremental amount.The amount of rotation of the indicator wheel is dependent upon thepitch of the worm, the number of worm threads and the pitch of the wormgear and the number of worm gear teeth. In a preferred embodiment, theworm has a single thread.

[0093] For ease of manufacturing, it is desirable to provide as coarse apitch on each of the ratchet and worm gears as possible, although thegears are still defined as fine-toothed gears. However, it is alsointended that the indicator member make only a single revolution(single-cycle) corresponding to a complete evacuation of medicament fromthe container. Thus, when a large number of doses (on the order of 200or more) are contained within the canister, it is important for theratchet, worm and worm gear to provide a relatively high reductionratio, such that 200 linear reciprocal movements of the actuator membercorrespond to one or less revolutions of the indicator member. Becausethe ratchet gear and worm rotate together, it should be understood thatthe number of teeth on the ratchet gear and worm gear, and the number ofthreads of the worm, determine the ultimate reduction ratio between therotation of the ratchet gear and the rotation of the indicator wheel.

[0094] For example, when the container holds 240 metered doses, anacceptable ratio is realized if the ratchet is made relatively coarsewith 10 teeth and the worm gear is provided with 28 teeth. In operation,the dispensing of 10 metered doses will cause the worm to make onecomplete revolution so as to thereby move the worm gear one tooth. After240 linear reciprocal movements, the worm gear has been advanced by 24teeth. Extra teeth are provided so that the starting and ending indicia,indicating a relative fullness or emptiness of the containerrespectively, are not labeled one on top of the other.

[0095] In a preferred embodiment, shown in FIGS. 9 and 15, the worm gear52 has teeth formed around only a portion of its periphery so that a gapis formed between the teeth around the remaining portion of theperiphery. In operation, the gears are configured so that the worm 40disengages from the last tooth of the worm gear as the final prescribeddose of medicament is dispensed. In this position, the indicia on theindicator wheel 58 will indicate to the user that the canister is empty.Therefore, although the user can continue to move the container so as toopen the valve, the resultant movement of the actuator 70, ratchet gear32 and worm will not in turn rotate the indicator member as the gap inthe teeth on the worm gear results in the disengagement of the worm andworm gear. In this way, the indicator wheel is prevented from beinginadvertently rotated from a full to empty reading and then back againto a full reading, which could confuse the user about the number ofdoses remaining in the canister.

[0096] The indicator wheel 58, indicia 66 and viewing window 28 can bearranged in a variety of configurations for viewing by the user. Forexample, the viewing window 28, 124 can be configured as a rectangularshaped window as shown in FIG. 2 or 10 respectively, as an arcuateshaped window 29 as shown in FIG. 4, wherein approximately ⅓, of theface of the indicator wheel is visible at any time, as a circular shapedwindow (not shown) or as any other shape allowing the user to view theindicator wheel and the indicia located thereon. In one embodiment, theindicia take the form of a color code, where, for example, a portion ofthe wheel is colored green to indicate the starting full position, aportion is colored yellow to indicate a medium fullness and a portion iscolored red to indicate that the container is empty. Obviously, othercolors, shading or alpha-numerical indicia can be provided on theindicator wheel to indicate the relative fullness or emptiness of thecontainer.

[0097] In an alternative embodiment, the indicator wheel can be orientedwithin the housing such that either its planar face or itscircumferential surface, with indicia applied thereto, are visible tothe user through the exhaust port of the mouthpiece.

[0098] Referring to FIG. 25, an alternative embodiment of an indicatorassembly is shown. The indicator assembly includes three indicatormembers 550 coaxially mounted on an axle 556 and rotatable thereabout.As best shown in FIGS. 28 and 29, each of the indicator members includesan indicator wheel 558 having a circumferential skirt 559 with an outercircumferential surface 560 on which indicia (shown as numbers) areapplied, and a ratchet gear 552 coaxially mounted with the indicatorwheel. The indicator wheel and ratchet gear have an opening 553 shapedto receive the axle. The ratchet gear 552 includes a plurality of teeth554 formed around its periphery. The ratchet gear is preferablyintegrally molded with the indicator wheel, although it should beunderstood that the gear and wheel can be made separately and thereafterattached one to the other by welding, adhesive and the like.

[0099] In one embodiment of the indicator member, a resilientadvancement member 600 is formed from a portion of the circumferentialskirt 559 by providing an elongated cutout 602 in the indicator wheelradially inward from and beneath the skirt. The advancement member 600includes a laterally extending tooth portion 604 having an engagementsurface 606. The three indicator members are coaxially mounted such thatthe tooth portion 604 of the advancement member of a first indicatormember overlies the ratchet gear teeth 554 of the second indicatormember, and such that the tooth portion 604 of the advancement member ofthe second indicator member overlies the ratchet gear teeth 554 of thethird indicator member. When only three indicator members are used (asshown in FIG. 25), the third indicator member does not require anadvancement member, although for the sake of simplicity inmanufacturing, a modular indicator member with the same indicia appliedthereto and the same advancement member formed thereon is preferablyused for each of the first, second and third indicator members. Itshould be understood by one of skill in the art that one or moreindicator members may be used to provide an indication of dosages usedor available, and that the three indicator members shown in the Figuresis meant to be illustrative, rather than limiting. In addition, itshould be understood that a plurality of indicator members refers to anynumber of indicator members greater than one.

[0100] In an alternative embodiment of the indicator member 650, shownin FIGS. 39, 42 and 43, an advancement member 800 is disposed radiallyinward from a circumferential skirt 659 and includes a first end 657connected to a planar side portion or hub 655 of the indicator wheel.The advancement member includes a curved resilient portion 708 having afree end with a tooth portion 704 extending laterally outward therefromso as to extend laterally from beneath the skirt 659 of the indicatorwheel such that it overlies the teeth of the ratchet gear of an adjacentindicator member coaxially mounted therewith as shown in FIG. 48.Indicia, preferably in the form of numbers, are applied to thecircumferential surface 660 of the skirt. A ratchet gear 652, having aplurality of teeth 654 is coaxially mounted with the indicator wheel. Asshown in FIG. 48, three indicator members are coaxially mounted on axle656.

[0101] Referring to FIGS. 25 and 39, an actuator member 570, 670,otherwise referred to as a ratchet member, is shown as having an upperportion 574, 674 extending upwardly from a lower portion 578, 678 and aresilient arm member 580, 680 extending outwardly therefrom andterminating in a resilient hook member 582, 682 shaped to selectivelyengage at least one of the teeth of the ratchet gear of the firstindicator member. A spring 588, 688 is disposed around the lower portionof the actuator member and biases the upper portion 574, 674 of theactuator member into engagement with the container.

[0102] Referring to FIG. 27, a housing 820 is shown as having a pair ofengagement members 770 formed integrally with the housing and includingramped surfaces 772. A plurality of non-return members 900 extend fromthe housing and selectively engage the ratchet gear to ensureunidirectional rotation of the indicator member as shown in FIGS. 35-38.Although the engagement members and non-return members are shown asbeing formed in or extending from a module housing, as described below,one of skill in the art should understand that those members orequivalent features could also be formed in or connected to thedispenser housing or actuator boot that supports the container, ordisposed on or connected to the container itself.

[0103] Referring to FIGS. 25 and 35-38, the operation of the indicatorassembly shown in FIG. 25 is generally shown. In particular, thecontainer is moved longitudinally within the housing 10 so as to depressthe valve stem 110 to the open position so as to open the valve asexplained above. As the container is moved downwardly within thehousing, or downwardly with respect to the module housing describedbelow, the actuator member 570 is moved longitudinally downward suchthat the hook member 582 is biased outwardly by the ratchet gear 552 ona first outer indicator member. At the bottom of the stroke, the hookmember 582 slips into an underlying relationship with the teeth on theratchet gear. When the container is released by the user, the spring(not shown) within the container biases the container upwardly withinthe housing along the longitudinal axis such that the valve stem 110 andvalve are moved to the closed position within the container. As thecontainer moves upwardly, the resilient arm member 580 moveslongitudinally upward such that the hook member 582 rotates the firstindicator member a predetermined angular or incremented amountcorresponding to the pitch of the teeth disposed around the periphery ofthe ratchet gear. As the container and resilient arm member reach thetop of the stroke, wherein the valve stem and valve are moved completelyto the closed position, the resilient arm member 580 is positioned overthe ratchet gear for the next cycle. Alternatively, the operation of theactuator member and ratchet gear can be reversed as explained above withrespect to the embodiment shown in FIGS. 6-9.

[0104] Referring to FIGS. 39-41 and 44-48, a plurality of resilient armmembers 700 are shown as extending from a module housing so as to bealigned with the ratchet gears on each of the indicator members. The armmembers 700 each serve as a combined engagement member and non-returnmember. In particular, as shown in FIGS. 40 and 41, the arm member 700functions as a non-return member and includes an end portion that isbiased away from the teeth on the ratchet gear as the actuator member,or adjacent indicator member with its advancement member, is actuated toadvance the ratchet gear. The operation of the actuator member 670 andratchet gear is similar to the operation of the ratchet gear shown inFIGS. 6-9 as explained above. The arm member 700 snaps back so that theend portion engages one of the teeth of the ratchet gear so as to ensurethat the rotation of the ratchet gear is unidirectional. As shown inFIGS. 44-47, the arm member 700 overlying the ratchet gears of thesecond and third indicator members also serves as an engagement memberthat selectively engages the advancement members connected to theindicator members.

[0105] In operation, the reciprocal movement of the container relativeto the housing is repeated until the first indicator member 550, 650,and its ratchet gear, are rotated one complete revolution. Thepredetermined number of reciprocal movements required to advance thefirst indicator member one revolution is equal to the number of teethdisposed about the periphery of the ratchet gear 552, 652. As the firstindicator member is rotated by successive movements of the containerrelative to the housing, the advancement member 600, 800 of the firstindicator member is brought into selective engagement with theengagement member, configured as the ramped surface 772 formed in thehousing or as the upwardly extending arm member 700. In particular, theengagement member 700, 772 biases the tooth portion 604, 704 of theadvancement member into engagement with one of the teeth 554, 654 of theratchet gear on the second indicator member.

[0106] As the first indicator member is further rotated by successivemovements of the container relative to the housing, whether it be thedispenser housing for the container or the module housing describedbelow, the advancement member 600 engages one of the teeth on theratchet wheel of the adjacent indicator member and advances theindicator member a predetermined incremental angular amountcorresponding to the pitch of the ratchet gear teeth. The termincremental is meant to refer to the angular amount the indicator memberis moved by the advancement of one actuation, which corresponds to themovement of one tooth, regardless of whether the indicating device isindicating the number of doses left (e.g., counting down) or indicatingthe number of doses administered (e.g., counting up).

[0107] As the resilient advancement member 600, 800 clears theengagement member 772, 700, it springs away from the ratchet gear suchthat further advancements of the first indicator member do not effect arotation of the second indicator member until the first indicator membercompletes yet another cycle so as to again bring the advancement memberinto engagement with the next tooth of the second indicator memberratchet gear, and so on. The second indicator member 550, 650 with itsadvancement member 600, 800, similarly interacts with a secondengagement member overlying the teeth of the third indicator member soas to selectively engage and advance the third indicator member apredetermined incremental amount for each complete rotation of thesecond indicator member. It should be understood that more indicatormembers could be similarly assembled to provide an incrementalindicating device.

[0108] In a preferred embodiment of the dispensing device, shown inFIGS. 6-10, 13-18, 20, 24, 25 and 39, the indicator assembly is arrangedin an indicator module 120, 1020, 1120. The indicator module 120, 1020,1120 is shaped to be received within the housing where it is disposedaround a portion of the support block 16. In particular, the supportblock is spaced apart from the wall of the dispenser housing, otherwisereferred to as the actuator boot, so as to form a donut-shaped socket inthe bottom of the housing. The module includes a module housing 130,1030, 1130 having an inner concave surface 132, 1032, 1132 that isshaped to mate with an outer convex surface of the cylindrical supportblock and an outer convex 134, 1034, 1134 surface that is shaped to matewith the inner concave surface of the housing which is also generallycylindrical. In this way, the module housing is shaped to be receivedwithin the socket formed around the support block. Preferably, themodule housing has a semicircular shape and fits around a portion of thesupport block opposite the orifice opening so as to not interfere withthe dispensing of the medicament, or the airflow transmitting themedicament to the patient. In this way, the module is maintainedrearwardly of the midpoint of the support block. One of skill in the artshould understand, however, that the module, or module housing, can beconfigured in any number of different sizes and shapes so as to beaccommodated in a variety of housings or cap assemblies, with or withoutsupport blocks and the like.

[0109] As shown in FIGS. 8-9, one embodiment of the module preferablyincludes a face portion 210 that extends from the rear convex surface ofthe module and includes a module viewing window 64. The face portionsnaps into the housing viewing window opening (circular opening notshown) so as to secure the module thereto. As shown in an alternativeembodiment in FIGS. 10-12, the face portion includes a verticallyoriented rectangular viewing window 68 and a downwardly extendinglocking member 122 which extends through the dispenser viewing windowopening 124 and engages a bottom wall of the housing. In yet otherembodiments, shown for example in FIGS. 24 and 30, the face portion1031, 1131 and viewing window 1064,1164 have an elongated horizontalorientation so as to provide the user with a view of the plurality ofindicator members mounted within the module. It should be understood,however, that the module can be secured within the housing by any numberof conventional means, including the use of fasteners or adhesive.Alternatively, the module can simply be press fit into the socket formedbetween the support block and housing wall.

[0110] In the embodiment shown in FIG. 8, the circular viewing window 64is provided in the module housing so as to expose a substantial portionof the planar indicator wheel. Numerical indicia, corresponding to thenumber of doses in the container, are provided on the face 60 of theindicator wheel. An arrow, or like indicator, is applied to the housingadjacent the viewing window and provides an indication of the number ofdoses remaining in the housing, or the number dispensed therefrom, asthe indicator wheel is rotated.

[0111] In other alternative embodiments, shown for example in FIGS. 10,11, 25 and 39, the indicia are applied to a circumferential surface 62,560, 660 of the indicator wheel. The module viewing window 68, 1064,1164, which is preferably rectangular, and indicator wheel are arrangedsuch that the circumference, or periphery, of the wheel, or wheels, isvisible through the module and dispenser viewing windows. As with theother embodiments, the indicia can take the form of color coding,shading, alpha-numerical characters and the like.

[0112] In the embodiments shown in FIGS. 28-29 and 42-43, the indiciaare preferably formed around the circumferential surface 560, 660 of theindicator wheel in the form of numbers ranging from 0 to 9, with theratchet gear on the indicator member having 10 teeth. In operation, itshould be understood that the three, or more or less, indicator memberscan be preset to the maximum number of dosages contained within thecontainer, with the indicia, or in this case numbers, arranged about theperiphery of the indicator wheel, such that successive, sequentialactuations of the container cause the indicator members to count down.

[0113] Alternatively, the indicator members are assembled such that thezero (0) of each indicator member is displayed in the viewing window tothe user. The container is then actuated by the user such that the firstindicator member rotates within the housing to sequentially display thenumber of doses that have been dispensed from 1 to 9. Upon the tenthactuation, the indicator member completes a single revolution, by virtueof the ten teeth preferably formed about the ratchet gear whichcorrespond to the predetermined number of actuations, and causes thesecond indicator member to advance one number from 0 to 1 as the firstindicator member again displays a 0 such that the two members togetherindicate that 10 dosages have been dispensed. The first indicator memberis again rotated by successive actuations until another single rotationis completed to further rotate the second indicator to reveal the 2, soas to indicate that 20 dosages have been dispensed. Upon a completerotation of the second indicator member, corresponding to 100actuations, the third indicator member is advanced to reveal a 1 in theviewing window with the first and second indicator members revealing a0, and so on.

[0114] As shown in FIG. 6-10, 13-18 and 20, one embodiment of theindicator assembly, including the worm, worm gear, ratchet gear andindicator member, is mounted within the module housing 130. Similarly,the embodiments of the indicator assembly shown in FIGS. 25 and 39 arealso preferably supported in a module housing 1030, 1130. The modulehousing is preferably formed from a first and second cover member 136,138, 1036, 1038, 1136, 1138 although it should be understood that asingle, integral piece of material would also work, as would anyplurality of members joined together. Referring to FIGS. 6-10, 30 and 39the first cover member 136, 1136, 1036 has a vertical wall 140, 1140,1040 defining at least a portion of the outer convex surface 134, 1034,1134 shaped to mate with the inner surface of the housing as describedabove. The secondary viewing window 64, 1064, 1164 of the module isprovided in the vertical wall 140, 1040, 1140 so as to be aligned withthe viewing window of the housing when the module is installed therein.The viewing window is framed by the face portion. In one embodiment,shown in FIG. 9, the first member also includes a pair of opposingbearing seats 144 formed on an inner surface of the vertical wall. Thebearing seats 144 are shaped to support the ends of axle 42.Alternatively, as shown in FIGS. 27 and 30 a bearing seat or lug 1044can be formed on each of the first and second cover members. As bestshown in FIGS. 9 and 30, a post member 146, 1046 extends upwardly from abase 150, 1050 of the first member adjacent one of the bearing seats andhas a socket 148, 1048 formed coaxially therein. Alternatively, as bestshown in FIG. 39, the base 1150 is formed as part of the second covermember and includes an opening 1148 shaped to receive the lower portion678 of the actuator member.

[0115] Referring to FIGS. 8-9, the second cover member 138, 1038, 1138mates with the first cover 136, 1036, 1136 to form an enclosuretherebetween. The second cover member includes a vertical wall 152,1052, 1152, a portion of which defines the concave surface 132, 1032,1132 shaped to mate with the outer surface of the support block. Anupper horizontal flange 154, 1054, 1154 extends from the vertical wall152, 1052, 1152 and mates with the vertical wall of the second member inoverlying relationship therewith so as to close off the top of themodule. In an alternate embodiment, the upper flange 1154 is formed aspart of the first cover member. The upper flange 154, 1054, 1154 has anopening 156, 1056, 1156 formed therein which is shaped to receive theupper portion 74, 574, 674 of the post member. In one embodiment, theupper surface of the flange is maintained parallel with or below the topsurface of the support block so as not to interfere with the containeras it is depressed toward the support block. Alternatively, as shown inFIGS. 8 and 9, the module housing is provided with a semi-circularrecess 155 shaped to receive the hub as the container is actuatedwhereby the surface 108 of the container engages the upper portion 74 ofthe actuator member and the surface 108 is positioned adjacent to thesurface 154 of the module housing when the valve is moved to the openposition. A bottom edge 158 of the vertical wall mates with the base 150of the first cover member to close off the bottom of the module. Asshown in FIGS. 8-9, 25-27 and 30, the cover members are joined byslidably engaging vertical flanges 160, 1060 on the first cover memberwith grooves 162, 1062 formed on the second cover member. Inwardlyextending tabs 220, 1061 snap fit into slots 222, 1063 formed in thesecond cover member. In the embodiment shown in FIGS. 26, 27 and 30, atab member 1067 engages opening 1071 formed in a wall member 1069 thatfurther defines a portion of the outer concave surface of the modulehousing. Alternatively, it should be understood that the first andsecond cover members can be joined with fasteners, adhesive and thelike.

[0116] As best shown in FIGS. 7, 15, 32 and 48, when the cover membersare assembled to form the module housing, the upper portion 74, 574, 674of the post member extends through the opening in the upper flange ofthe first cover member and engages the top surface 108 of the container,which is inverted in the housing. Alternatively, the actuator member canbe attached to the hub of the container with the locking ring aspreviously described. In such an embodiment, the arm member of theactuator member extends downwardly from the ring through the opening inthe top of the first cover member and is positioned to selectivelyengage the ratchet gear. The insertion of the arm in the openingprevents the canister and attached locking ring from being rotated so asto move the arm member out of position for selective engagement with theratchet gear.

[0117] As best shown in FIGS. 9 and 25, the lower portion 78, 578 of thepost member is moveably received within the socket 148, 1048 formed inthe post member 146, 1040 extending from the base of the second covermember. Alternatively, the lower portion 678 is received in the opening1148 as shown in FIG. 39. Referring to FIGS. 9, 25 and 39, spring 88,588, 688 is disposed about the lower portion 78, 578, 678, and incertain embodiments includes a lower end mounted on the post member 146,1046. The upper end of the spring engages the lower stop surface 86,586, 686 of the post member 72, 572, 672. The spring biases the postmember upwardly within the housing such that the upper portion 74, 574,674 protrudes through the opening and into engagement with the topsurface of the container 108.

[0118] In one embodiment, shown in FIGS. 8 and 9, the worm 40 andratchet gear 32 are rotatably supported on the bearing seats 144 formedin the second member. Preferably, opposite ends of axle 42 are snapfitted into the bearing seats. The indicator member 50 is rotatablysupported by the second cover member such that the worm gear engages theworm when the cover members are joined together. In particular, thesecond cover includes a pair of downwardly opening lug members 164, 166.The axle 56 of the indicator member is received in the first lug member164 and a hub portion 59 positioned between the worm gear and theindicator wheel is received within the second lug member 166.Preferably, the axle and hub are snap fitted into the lugs, but arepermitted to freely rotate therein. When the cover members are joined,the indicator member, and in particular the worm gear, are trappedbetween the lug members and the worm.

[0119] In an alternative embodiment shown in FIGS. 25-27 and 30, theaxle 556 is supported on opposite ends by the lug portion 1044 extendingfrom each of an upper and lower cover members 1036, 1038. The axle 556has a T-shaped cross-section formed as a result of a molding process,e.g., when the axle is integrally formed or molded with one or more ofthe module housing cover members. The shape of the axle also permits itto act as a key member when received in similarly shaped sockets formedin one or more of the lug portions. The axle extends outwardly from thelug portion. The axle includes opposite curved surfaces 555, 557, asbest shown in FIGS. 35-38 that provide a supporting surface for theindicator members that are rotatably mounted thereon. One of skill inthe art should understand that the axle could have a circularcross-section and could be rotatably mounted to the housing. In such anembodiment, at least one of the indicator members can be integrallyformed with the axle, or all of the member can be separately mountedthereon.

[0120] It should be understood that in the alternative embodiment ofFIGS. 2-5, the supporting structure for the worm and ratchet, includingthe bearing seats or like supports, and the supporting structure for theindicator member, including the lug members, are similar to thestructure provided in the module housing, but are integrally molded intothe housing. Similarly, a post and socket member can be integrallymolded into the bottom of the dispenser housing so as to support theactuator member and spring.

[0121] Similarly, although the indicator assembly embodiments of FIGS.25 and 39 are shown as preferably being mounted in the indicator module,one of skill in the art should understand that the assembly, includingthe axle, indicator members, actuator member and spring could be mounteddirectly in the dispenser housing or actuator boot that supports thecontainer. Similarly, the engagement member, or members, and non-returnmember, or members, could be formed in the dispenser housing thatsupports the container, otherwise referred to as the actuator boot.

[0122] In an alternative embodiment shown in FIG. 19, a lower portion172 of the outer vertical wall of the module housing is angled so as toa mate with a housing having a similar angled planar bottom surface. Asshown in FIG. 19, the axis of rotation of the indicator member isoriented at an angle of approximately 45 degrees from the longitudinalaxis so that the face of the indicator wheel 60 is substantiallyparallel to the angled surface of the housing. A viewing window isprovided in the angled surface 172 and is aligned with a similar viewingwindow provided in the angled wall of the dispenser housing.

[0123] Now referring to FIGS. 21-23, a key member 300 is shown asincluding a base portion 302 having a recess 304 shaped to receive thetop of the container. The base portion is circular shaped and is open inthe middle. The key member is mounted on the container by press fittinga circumferential flange 306, which forms the recess, about thecontainer such that the valve stem and hub passes through an opening 308formed in the middle of the key member. Alternatively, the key membercan be mounted to the container with adhesive or other fasteners. Thekey member also includes a key portion 310 extending downwardly from thebase portion. The key portion is preferably configured as a circularflange member, although other shapes would also work.

[0124] In alternative embodiments shown in FIGS. 25 and 32-33, the keymember 1300 includes a mounting portion 1302, configured as a hoopmember having a plurality of ribbed portions 1304. The mounting member1302 is sized to fit over the end of the container such that the ribbedportions grip a portion of the container. A plurality of arm members1306 secure a key portion 1308 to the mounting member.

[0125] In another alternative embodiment shown in FIG. 34, the mountingmember 1402 has a smaller diameter than the key portion, and iscoaxially disposed with the key portion. A base member 1404 connects themounting member and key portion. The mounting member includes aplurality of inwardly facing tab members 1410 that engage an outertapered surface of the hub portion 106 of the container.

[0126] In the embodiments shown in FIGS. 25 and 34, the key portion1308, 1408 is formed as a circular flange member having a plurality ofopenings 1312, 1412 formed therein about the circumference thereof so asto allow air to flow through the key member with less restriction. Inthe embodiment shown in FIGS. 32 and 33, the key portion 1508 includestwo coaxially mounted key portions of different diameters, each with aplurality of openings 1512 to facilitate air flow therethrough.

[0127] The embodiment of the indicator module shown in FIG. 21 has a keyentry passageway configured as a recess 312 formed in an upper surfaceof the module housing. Preferably, in this embodiment, the recess isformed as an arcuate shaped, or semi-circular, slot. The actuator member314 extends upwardly from the module housing into the slot. The actuatormember 314 is maintained substantially flush with or below the uppersurface of the module 316. In this way, the actuator cannot be actuatedby a user's finger or the like so as to inadvertently advance theindicator member and thereby provide an inaccurate reading of the numberof dosages remaining in the container, or the number dispensedtherefrom.

[0128] The shape or diameter of the key portion and corresponding entrypassageway are configured so that the key portion communicates with andis received in the passageway formed in the module housing. When thecontainer is mounted in the dispenser housing such that the valve stemis received in the well in the support block, the key portion isreceived in the passageway and engages the actuator member.

[0129] In an alternative embodiment of the dispensing device, with orwithout an indicator module or indicator assembly, a key entrypassageway can be formed directly in the dispenser housing, e.g., in abottom portion of the dispenser housing, wherein it receives a keyportion disposed on the container. It should be understood that the term“housing,” as used herein, can refer to the dispenser housing, theindicator module housing, or a combination of those housings.

[0130] In yet another alternative embodiment, the key portion and keyentry passageway are reversed. In this embodiment, the key portion isformed on the housing, i.e., the indicator module housing, or thedispenser housing if the dispensing device lacks an indicator moduleand/or an indicator assembly, and the key entry passageway is formed inthe container. For example, the module housing, or dispenser housing,can include a ring member that is received in a ring-shaped recessformed in the hub of the container. Or, the dispenser housing or modulehousing can be configured to include one or more protuberances that arereceived in one or more recesses formed in the container.

[0131] In this way, key members having differently shaped key portionscan be applied to containers holding different types of substances, suchas a medicament, so as to prevent the user from mixing up the containersand dispensers. In operation, a container having a certain key memberwith a specific key portion can be installed only in a dispenser housinghaving a passageway shaped to receive that key portion. If the keyportion does not fit the recess, the key ring will engage the uppersurface of the module housing so as to prevent the actuation of thecontainer relative to the dispenser housing and the attendant opening ofthe valve. This in turn prevents a user from installing containershaving different substances in different dispensers, which could therebyadversely affect the counting of doses dispensed from the container, orthe counting of the number of doses remaining therein. For example, akey member having a key portion with a thickness of 1 mm and an innerdiameter of 13mm is prevented from being installed in a passagewayhaving a width of 1mm and an inner diameter of 15 mm, and vice versa.

[0132] It should be understood that the mating key member and key entrypassageway can also be used with various delivery systems that do notinclude an indicating device, as explained above. Often, deliverysystems can be configured to deliver a specific type of substance.Because a differently configured delivery system may not maximize thedelivery of the intended substance, such as a medicament, it may beimportant to ensure that a specific delivery system is used with aparticular substance. In this way, a mating key member and key entrypassageway can be mounted on one or the other of the container andhousing, or similar structure, of the delivery system so as to ensurethat the proper container is installed in the proper delivery system.

[0133] In the alternative embodiment of FIG. 25, the module housingincludes three pairs of upstanding members 1080, 1082 forming a slot orrecess 1084 between each pair. In addition, the upstanding members ofone pair 1082 are formed as channels opening towards each other. Theelongated recess 1056 formed between the pair of members is shaped toreceive the upper portion of the actuator member 574. In operation, thekey portion 1308 of the key member is shaped to be received in thevarious radially formed slots or recesses, or key entry passageways, soas to engage the actuator member disposed in the elongated recess. Whenthe container is moved with respect to the module housing so as to movethe valve to the open position, the hub of the container nests in arecess formed between the inner upstanding member of each pair.

[0134] In the embodiment shown in FIGS. 32 and 33, three sets of threeupstanding members 1180, 1182 are provided, with each set of threehaving two slots 1184 formed between the members so as to be shaped toreceive the two key portions 1508 of the key member 1500. Again, one setof three members 1182 forms an elongated passageway, or recess 1056,that is shaped to receive the actuator member. The two key portionconfiguration allows for multiple combinations of shapes and diametersof key portions so as to provide for a different key combination foreach of the multiplicity of substances being dispensed from the variouscontainers.

[0135] Although the circular configurations of the key portion andcorresponding slots shaped to receive the key portion, as shown in thefigures, are preferred since they allow the container to be rotatedwithin the dispenser housing about its longitudinal axis, it should beunderstood that the key portion and slot, or like passageway or keyhole,can be shaped in any type of mating configuration and that the matingshapes are not limited to the circular configuration shown in thefigures.

[0136] The indicator module provides an inexpensive and accurate devicefor counting dosages of medicament and the like. The module can be sizedfor easy installation as a separate unit in most conventional inhalationhousings with minimal modification of the housing, including providing aviewing window in the housing in alignment with the module viewingwindow and the removal of any structure formed between the support blockand outer wall of the housing. In addition, the module can be installedrearwardly of the support block so as not to interfere with or otherwiseimpede the air flow dispensing the medicament.

[0137] Although the present invention has been described with referenceto preferred embodiments, those skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention. As such, it is intended that the foregoingdetailed description be regarded as illustrative rather than limitingand that it is the appended claims, including all equivalents thereof,which are intended to define the scope of the invention.

What is claimed is:
 1. An indicating device for a dispensing device thatdispenses metered dosages of a medicament from a container having avalve moveable between a closed position and an open position, saidcontainer dispensing said metered dosage when said valve is moved to theopen position, said indicating device comprising: a housing comprisingat least one engagement member; a plurality of indicator memberscoaxially mounted in said housing and comprising at least a first andsecond indicator member, at least one of said indicator members havingdosage indicia, at least one of said first and second indicator memberscomprising an advancement member and at least the other of said firstand second indicator members comprising a plurality of teeth, whereinsaid engagement member is adapted to selectively engage said advancementmember so as to bias said advancement member into operable engagementwith at least one of said plurality of teeth of said at least oneindicator member as said first indicator member is rotated relative tosaid second indicator member, whereby said advancement member causessaid second indicator member to rotate an incremental amount.
 2. Theinvention of claim 1 further comprising an actuator member mounted insaid housing and responsive to said movement of said valve, and whereinsaid first indicator member comprises a plurality of teeth, saidactuator member adapted to selectively engage at least one of saidplurality of teeth on said first indicator member so as to advance saidfirst indicator member an incremental amount in response to saidmovement of said valve.
 3. The invention of claim 2 further comprising aspring disposed in said housing and adapted to bias said actuator memberinto engagement with said container.
 4. The invention of claim 1 furthercomprising a third indicator member coaxially mounted in said housingwith said first and second indicator members, wherein at least one ofsaid second and third indicator members comprises an advancement memberand at least the other of said second and third indicator memberscomprises a plurality of teeth, and said housing further comprising atleast a second engagement member, wherein said second engagement memberis adapted to selectively engage said advancement member of at least oneof said second and third indicator members so as to bias saidadvancement member into operable engagement with at least one of saidplurality of teeth of said other indicator member as said secondindicator member is rotated relative to said third indicator member,whereby said advancement member causes said third indicator member torotate an incremental amount.
 5. The invention of claim 1 wherein saidhousing further comprises at least one non-return member selectivelyengaged with at least one of said plurality of said teeth of at leastone of said plurality of indicator members.
 6. The invention of claim 5wherein said engagement member and said non-return member are integrallyformed as a single member.
 7. The invention of claim 1 wherein saidengagement member comprises a ramped surface.
 8. The invention of claim1 wherein said engagement member comprises a resilient arm memberextending from said housing.
 9. The invention of claim 1 wherein saidhousing comprises a first housing disposed in a second housing, whereinsaid plurality of indicator members are mounted in said first housingand wherein said second housing is adapted to support said container.10. The invention of claim 1 wherein said housing comprises a dispenserhousing adapted to support said container.
 11. The invention of claim 1wherein said housing comprises a viewing window, said indicia exposed tothe user in said viewing window.
 12. The invention of claim 1 wherein atleast one of said indicator members comprises an indicator wheel havinga circumferential surface, said dosage indicia applied to saidcircumferential surface.
 13. The invention of claim 12 wherein said atleast one of said plurality of indicator members further comprises aratchet gear coaxially mounted with said indicator wheel and attachedthereto, said ratchet gear comprising said plurality of teeth.
 14. Theinvention of claim 1 wherein at least one of said indicator memberscomprises an indicator wheel having a circumferential skirt.
 15. Theinvention of claim 14 wherein said advancement member is formed from aportion of said circumferential skirt.
 16. The invention of claim 14wherein said advancement member is disposed radially inward from saidcircumferential skirt.
 17. The invention of claim 1 wherein saidadvancement member includes a tooth portion adapted to engage said atleast one of said plurality of teeth of said adjacent indicator member.18. The invention of claim 1 further comprising a key member having akey portion, said key member adapted to be mounted to said container,and wherein said housing comprises a passageway shaped to receive saidkey portion.
 19. A device for dispensing metered dosages of a medicamentfrom a container, said device comprising: a housing having alongitudinally extending cavity and a well located at a bottom of saidcavity, said housing having an exhaust port communicating with saidwell; said container comprising a valve stem extending longitudinallytherefrom and moveable between a closed position and an open position,said container containing a plurality of metered dosages of saidmedicament, said valve stem dispensing one of said plurality of saidmetered dosages when said valve stem is moved to the open position, saidcontainer disposed in said cavity of said housing and said valve stemreceived within said well, said container reciprocally moveable withinsaid housing along said longitudinal extent of the cavity such that saidvalve stem is moved between said open and closed position by engagementwith said well; at least one engagement member disposed in said housing;a plurality of indicator members coaxially mounted in said housing andcomprising at least a first and second indicator member, at least one ofsaid plurality of indicator members comprising dosage indicia, at leastone of said first and second indicator members comprising an advancementmember and at least the other of said first and second indicator memberscomprising a plurality of teeth, wherein said engagement member isadapted to selectively engage said advancement member so as to bias saidadvancement member into operable engagement with at least one of saidplurality of teeth of said at least one of said first and secondindicator members as said first indicator member is rotated relative tosaid second indicator member, whereby said advancement member causessaid second indicator member to rotate an incremental amount.
 20. Theinvention of claim 19 further comprising an actuator member disposed insaid housing and responsive to said movement of said container relativeto said housing, said first indicator member comprising a plurality ofteeth, said actuator member adapted to selectively engage at least oneof said plurality of teeth on said first indicator member so as toadvance said first indicator member an incremental amount in response tosaid movement of said container relative to said housing.
 21. Theinvention of claim 20 further comprising a spring disposed in saidhousing and adapted to bias said actuator member into engagement withsaid container.
 22. The invention of claim 19 further comprising a thirdindicator member coaxially mounted in said housing adjacent said secondindicator member, wherein at least one of said second and thirdindicator members comprises a resilient advancement member and at leastthe other of said second and third indicator members comprises aplurality of teeth, and said housing further comprising at least asecond engagement member, wherein said second engagement member isadapted to selectively engage said advancement member of at least one ofsaid second and third indicator members so as to bias said advancementmember into operable engagement with one of said plurality of teeth ofsaid other indicator member as said second indicator member is rotatedrelative to said third indicator member, whereby said advancement membercauses said third indicator member to rotate an incremental amount. 23.The invention of claim 19 further comprising at least one non-returnmember disposed in said housing and selectively engaged with at leastone of said plurality of teeth of at least one of said plurality ofindicator members.
 24. The invention of claim 23 wherein said engagementmember and said non-return member are integrally formed as a singlemember.
 25. The invention of claim 19 wherein said housing comprises afirst housing, and wherein a second housing is disposed in said firsthousing, said plurality of indicator members coaxially mounted in saidsecond housing.
 26. The invention of claim 25 wherein said engagementmember comprises a ramped surface formed in one of said first and secondhousings.
 27. The invention of claim 25 wherein said engagement membercomprises a resilient arm member extending from one of said first andsecond housings.
 28. The invention of claim 19 wherein said housingcomprises a viewing window, said indicia exposed to the user in saidviewing window.
 29. The invention of claim 19 wherein at least one ofsaid indicator members comprises an indicator wheel having acircumferential surface, said dosage indicia applied to saidcircumferential surface.
 30. The invention of claim 29 wherein said atleast one of said indicator members further comprises a ratchet wheelcoaxially mounted with said indicator wheel and attached thereto, saidratchet wheel comprising said plurality of teeth.
 31. The invention ofclaim 29 wherein said advancement member is integrally formed as anouter circumferential portion of said at least one indicator member. 32.The invention of claim 19 wherein said advancement member includes atooth portion adapted to engage said at least one of said plurality ofteeth of said adjacent indicator member.
 33. The invention of claim 19further comprising a key member disposed on said container, said keymember comprising a key portion, and wherein said housing comprises apassageway shaped to receive said key portion.
 34. An indicator moduleadapted to be received within a dispenser housing said indicator modulecomprising: a module housing dimensioned to be received within saiddispenser housing; and a plurality of indicator members mounted in saidmodule housing, each of said plurality of indicator members comprisingdosage indicia.
 35. The invention of claim 34 further comprising anactuator member adapted to engage a container having a valve moveablebetween a closed position and an open position, said containerdispensing a metered dosage of medicament when said valve is moved tothe open position, said actuator member moveable within said modulehousing and selectively engaged with at least one of said indicatormembers to move said at least one indicator member in response to themovement of said valve.
 36. The invention of claim 35 further comprisinga spring disposed within said module housing and engaging said actuatormember so as to bias said actuator member upwardly within said modulehousing.
 37. The invention of claim 34 wherein said plurality ofindicator members are coaxially mounted within said module housing. 38.The invention of claim 34 wherein said module housing comprises a firstand second member joined to form an enclosure.
 39. The invention ofclaim 34 further comprising a viewing window formed in said modulehousing.
 40. The invention of claim 34 wherein said module housing has akey entry passageway formed therein.
 41. A method for dispensing metereddosages of a medicament from a container, said method comprising thesteps of: providing a housing; providing said container filled with apredetermined number of measured dosages of medicament, said containersupported in said housing, said container comprising a valve moveablebetween a closed and open position, said container adapted to dischargea measured dosage when said valve is moved to the open position; movingsaid valve to the open position so as to thereby discharge a measureddosage; moving said valve to the closed position; rotating a firstindicator member rotatably mounted in said housing a predeterminedamount in response to at least one of said movements of said valve;rotating a second indicator member a predetermined amount upon apredetermined number of movements of said valve and in response to therotation of said first indicator member, said second indicator membercoaxially mounted in said housing with said first indicator member; andproviding indicia on at least one of said first and second indicatormembers.
 42. The invention of claim 41 wherein said housing comprises awell and an exhaust port, said well communicating with said exhaustport, and wherein said container comprises a valve stem received in saidwell of said housing, and wherein said moving said valve to the openposition comprises moving said container relative to said housing so asto move said valve stem to the open position, and wherein said movingsaid valve to the closed position comprises moving said containerrelative to said housing so as to move said valve stem to the closedposition, and wherein said rotating said first indicator member is inresponse to at least one of said movements of said container relative tosaid housing.
 43. The invention of claim 42 further comprising the stepsof engaging an actuator member with said container such that actuatormember moves in response to the movement of the container within thehousing along a longitudinal axis, and engaging said first indicatormember with said actuator member so as to rotate said first indicatormember said predetermined amount in response to the longitudinalmovement of the container within the housing.
 44. The invention of claim43 wherein said actuator member comprises an arm having an end adaptedto selectively engage and rotate the first indicator member.
 45. Adispensing device for dispensing metered dosages of a medicament from acontainer, said dispenser device comprising: a dispenser housing; saidcontainer disposed in said housing; a dose indicator module comprising aplurality of indicator members, said dose indicator module mounted insaid housing.
 46. The invention of claim 45 wherein said dispenserhousing comprises a support block and a wall spaced apart from saidsupport block, said support block having a well, wherein said containercomprises a valve stem, said valve stem mounted in said well, andwherein said dose indicator module comprises a module housing shaped tobe received in the space between the support block and the housing wall.47. The invention of claim 45 wherein said dose indicator module furthercomprises a viewing window whereby at least one of said indicatormembers is visible to a user through the viewing window.
 48. Theinvention of claim 45 wherein said dispenser housing further comprises aviewing window, wherein said indicator member is visible to the userthrough the viewing window.
 49. The invention of claim 45 wherein saidmodule housing comprises a first and second member joined to form anenclosure.
 50. The invention of claim 46 further comprising a key membermounted to said container and wherein said module housing has apassageway formed therein, said key member shaped to be received in saidpassageway as said valve stem of said container is mounted in said wellof said support block.
 51. The invention of claim 50 wherein said doseindicator module further comprises an actuator member extending intosaid passageway, wherein said key member engages said actuator memberwhen received in said passageway.
 52. The invention of claim 51 whereinsaid module housing comprises an upper surface and wherein said actuatormember is substantially flush with said upper surface when disengagedfrom said key member.
 53. The invention of claim 50 wherein saidpassageway comprises a slot.
 54. A kit having components capable ofbeing assembled as a dispensing device for dispensing metered dosages ofa medicament from a container, the kit comprising: a housing having alongitudinally extending cavity and a well located at a bottom of saidcavity; said container comprising a valve stem extending longitudinallytherefrom, said container containing a plurality of metered dosages ofsaid medicament, said valve stem adapted to be received in said well ofsaid housing; and an indicator module comprising an indicator member,said indicator module adapted to be mounted in said bottom of saidcavity of said housing.
 55. An indicating device for a dispenser thatdispenses metered dosages of a medicament from a container having avalve moveable between a closed position and an open position, saidcontainer dispensing said metered dosage when said valve is moved to theopen position, said indicating device comprising: a housing; a pluralityof indicator members coaxially mounted in said housing and comprising atleast a first and second indicator member; and means for advancing saidsecond indicator member relative to said first indicator member.
 56. Theinvention of claim 55 wherein said housing is adapted to moveablysupport said container, and further comprising means for advancing saidfirst indicator member in response to the movement of said containerrelative to said housing.
 57. The invention of claim 55 wherein saidmeans for advancing is disposed in an indicator module, said indicatormodule disposed in said housing.
 58. An indicating device for adispensing device that dispenses metered dosages of a medicament from acontainer having a valve stem extending longitudinally therefrom andmoveable between a closed position and an open position, said containerdispensing said metered dosage when said valve stem is moved to the openposition, said indicating device comprising: a housing adapted to moverelative to said container as said container is moved between said openand closed positions; a plurality of indicator members coaxially androtatably supported in said housing, each of said indicator memberscomprising indicia applied to a circumferential surface thereof andvisible to the user, said plurality of indicator members selectively andoperably connected such that successive movements of said containerrelative to said housing causes at least one of said indicator membersto rotate, whereby said indicia visible to the user is changed toindicate the dispensing of at least one metered dosage.
 59. Theinvention of claim 58 wherein said housing comprises a module housingdisposed in a dispenser housing, said dispenser housing adapted tomoveably support the container.
 60. The invention of claim 58 whereinsaid housing comprises a dispenser housing adapted to support thecontainer.
 61. The invention of claim 58 wherein said plurality ofindicator members comprises at least a first and second indicatormember, said first indicator member selectively and operably engagedwith said second indicator member upon successive rotations of saidfirst indicator member so as to rotate said second indicator member anincremental amount for each successive rotation of said first indicatormember.
 62. The invention of claim 61 further comprising an actuatormember operably engaged with said container, wherein said actuatormember rotates said first indicator member an incremental amount inresponse to said movement of said container relative to said housing.63. A delivery system for delivering a medicament to a user, saiddelivery system comprising: a housing; a container holding a medicament;and a key member disposed on one of said housing and said container, andthe other of said housing and said container having a passageway;wherein said container is capable of being operably connected to saidhousing when said key member is shaped to be received in saidpassageway, and wherein said container is prevented from being operablyconnected to said housing when said key member is not shaped to bereceived by said passageway.
 64. The invention of claim 63 wherein saidhousing includes a dispenser housing having a longitudinally extendingcavity and a well, and wherein said container comprises a valve stem,said container operably connected to said dispenser housing when saidvalve stem is mounted in said well such that said container can be movedreciprocally longitudinally within said cavity.
 65. The invention ofclaim 63 wherein said key member is disposed on said container and saidpassageway is formed on said housing.
 66. The invention of claim 64wherein said housing further comprises a module housing disposed in saiddispenser housing, wherein one of said key passageway and said keymember is formed on said indicator module housing.
 67. The invention ofclaim 63 wherein said key member is disposed on said housing and saidpassageway is formed on said container.